Skip to main content
KK
Open to opportunities

Kateryna Konovalenko

@katerynakonovalenko

Clinical Affairs Manager at Sonova, with regulatory affairs experience across medical devices and a focus on clinical evaluation and compliance.

Switzerland
Message

At Sonova Gruppe, I moved from Regulatory Affairs Specialist to Regulatory Affairs Manager and now work as Clinical Affairs Manager. As a specialist, I supported CE marking and international registration for Class I and IIa active medical devices.

I also served as Global Process Owner for Vigilance and Post Market Surveillance. My regulatory work has included navigating MDR alongside requirements such as ESPR, GPSR, RoHS, and REACH.

At SCHMID RHYNER AG, I worked on product compliance with European and international chemical regulations and food packaging requirements, and managed customer complaints end to end. At Syngenta, I supported an organisation and IT transformation project and maintained product registration data for assigned EMEA countries in TrackWise.

Earlier, at Celerion, I checked bioanalytical studies against GLP/GCP guidelines and SOPs, reviewing raw data, statistics, and reports. My education includes an MSc in Psychology focused on health psychology, wearable devices, and the human–technology interface, alongside training in clinical evaluation and digital health product development.

Experience

Work history, roles, and key accomplishments

Sonova Gruppe logoSG
Current

Clinical Affairs Manager

Jun 2024 - Present (2 years 4 months)

Worked as Clinical Affairs Manager at Sonova Gruppe.

Sonova Gruppe logoSG

Regulatory Affairs Manager

Apr 2022 - Jun 2024 (2 years 2 months)

Worked as Regulatory Affairs Manager at Sonova Gruppe.

Sonova Gruppe logoSG

Regulatory Affairs Specialist

Oct 2019 - Apr 2022 (2 years 6 months)

- Class I and IIa active medical devices;
- CE marking and international registration support;
- Global Process Owner Vigilance;
- Global Process Owner Post Market Surveillance

SCHMID RHYNER AG logoSA

Regulatory Affairs Coordinator and Complaint Manager

Apr 2018 - Aug 2019 (1 year 4 months)

Regulatory Compliance of the products with
- European Chemical Regulations (CLP, REACH, VOC etc.)
- Other international Chemical Regulations (21 CFR FDA, California Proposition 65, etc.)
- Food Packaging Regulations (EU 10/2011, Swiss Ordinance, Nestle Guidelines, EuPIA, BPA)

End-to-end Management of Customer Complaints

Environmental Management and Product Stewardship

Syngenta logoSY

Regulatory Specialist

May 2017 - Mar 2018 (10 months)

I was engaged in a large organisation and IT transformation project. As a Regulatory Data Specialist for EMEA region I was responsible for the quality of product registration data in assigned countries. Additionally, my tasks involved day-to-day maintenance of the European database of plant protection product registrations in TrackWise.

Celerion logoCE

Quality Control Specialist

May 2016 - Apr 2017 (11 months)

As a QC Specialist at Celerion AG I am responsible for controlling bioanalytical studies for adherence to GLP/GCP guidelines and current SOPs. Every day I am involved in a number of bioanalytical projects that apply different analytical methods (Ligand Binding Assays such as ELISA and RIA and LC-MS). To check the quality of the raw data, resulting statistic and final reports I employ a wide array

Education

Degrees, certifications, and relevant coursework

SO

Stanford Online

SOM-XCHE0025 - Digital Health Product Development

Mar 2026

IA

IPI Academy

Clinical Evaluation of Medical Device Software

Jan 2025

UO

University of Essex Online

Master of Science - MS, Psychology

2021 - 2024

Focus on Health Psychology, wearable devices, human - technology interface

TS

TÜV SÜD

Klinische Bewertung von Medizinprodukten

Nov 2024

IA

IPI Academy

Introduction to Design and Development of Medical Devices

Apr 2023

SA

SAQ-QUALICON AG

Environmental Management

Jun 2019

PI

Project Management Institute

Project Management CAPM

Feb 2016 · Expired Feb 2021

TS

TÜV SÜD

Project Management HERMES 5.1

Jun 2015

AB

Albert-Ludwigs-Universität Freiburg im Breisgau

Master of Science (MSc), Forest Ecology and Management

2010 - 2012

NA

National University of Kyiv-Mohyla Academy

Bachelor of Science (BSc), Environmental Sciences

2006 - 2010

Tech stack

Software and tools used professionally

Get matched with your dream remote job

Sign up now and join over 250,000+ remote workers who receive personalized job alerts, curated job matches, and more for free!

Sign up
Himalayas profile for an example user named Frankie Sullivan